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Screw-Integrated vs Traditional Cervical Cages in ACDF for Degenerative Disc Disease

NCT07430163 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-24

No results posted yet for this study

Summary

This study is a prospective, comparative clinical trial conducted at Assiut University Hospitals to evaluate the effectiveness of two different interbody fusion devices in patients with Cervical Degenerative Disc Disease (CDDD). The primary objective is to compare cervical cages with integrated screws against traditional stand-alone cervical cages during single or double-level Anterior Cervical Discectomy and Fusion (ACDF). While ACDF is the gold standard for CDDD, traditional cages can sometimes lead to complications like subsidence or incomplete fusion; integrated screw designs aim to provide immediate stability and reduce these risks.

Investigators will assess 40 patients over a 12-month follow-up period, focusing on primary outcomes of radiological interbody fusion using the Daniel Riew grading system.

Secondary outcomes include the maintenance of cervical alignment (Ishihara Index), change in segmental angles (Cobb's method), disc height restoration, and clinical improvements in pain and function measured by the Visual Analog Scale (VAS) and Neck Disability Index (NDI). The study's rationale is to provide clearer evidence on whether screw-integrated cages offer superior radiological and clinical outcomes to help guide future surgical preferences

Conditions

  • Cervical Cage With Screw
  • Cervical Degenerative Disc Disease
  • Anterior Cervical Discectomy and Fusion (ACDF)

Interventions

DEVICE

cervical cage with integrated screws

Anterior Cervical Discectomy and Fusion (ACDF) procedure performed using a cervical cage that features integrated screw fixation. This device provides immediate biomechanical stability without the need for an additional anterior plate

DEVICE

traditional standalone cervical cage

Standard Anterior Cervical Discectomy and Fusion (ACDF) procedure using a traditional standalone interbody fusion cage (without integrated screws). This serves as the control intervention to compare stability and fusion rates

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Mohamed Abdel-Hay El-Meshtawy · Assiut University, Faculty of Medicine, Orthopedic surgery and Traumatology.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-15
Primary Completion
2027-09-30
Completion
2027-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07430163 on ClinicalTrials.gov